Quality/GMPs

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

Policy makers seek to ensure supplies of new therapies and to limit shortages.

Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

Synthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.

With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.

The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Pharmaceutical Technology spoke with Jens Andersson, purchasing director at Cambrex Karlskoga, about the best way to ensure the security of the bio/pharmaceutical materials supply chain.

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.

The bill includes multiple less-noticed provisions to bolster healthcare programs and to advance the development of new treatments and preventives to combat the virus.